Summary of Product Characteristics
last updated on the eMC:
11/08/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 11/08/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 31-Dec-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7. Marketing Authorisation Holder
Address change:
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire CV31 3RW
United Kingdom.
10. Date of (Partial) Revision of the Text
Date change:
31/12/2007 (V1404-6)
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Updated on 20/08/2003 and displayed until 11/08/2009
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 3 - pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/02/2003 and displayed until 20/08/2003
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 7 - Marketing Authorisation Holder
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Updated on 15/08/2001 and displayed until 24/02/2003
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 02/08/2001 and displayed until 15/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 02/08/2001
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Reasons for adding or updating:
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